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A new paediatric formulation (oral liquid) has been developed for flexible and accurate dosing of valacyclovir in children. To establish the bioavailability of this new formulation, healthy volunteers will be exposed to the new formulation and to valacyclovir tablets. The concentration of valacyclovir in their blood after exposure to the oral liquid will be measured and compared to the tablet.
Bioequivalence of the new valcyclovir formulation will be tested according to the EMA guideline for bioequivalence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| valacyclovir tablet | Active Comparator | Administration of 500 mg once daily on day 1 (group A) or on day 8 (group B) |
|
| valacyclovir oral solution | Experimental | Administration of 500 mg once daily on day 1 (group B) or on day 8 (group A) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valacyclovir tablet | Drug | 16 healthy adult volunteers (18-55 yr) will be exposed to one tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Ratios and 90% confidence intervals of pharmacokinetic parameters of acyclovir taken as valacyclovir tablet or oral solution | bioequivalence will be determined by comparing AUC0-inf, Cmax and tmax of both formulations in healthy adult volunteers. | up to 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the safety profile of a single dose of valacyclovir oral solution | healthy volunteers will be interviewed for adverse events, laboratory safety assessments will be performed. | day 1 and 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bas Schouwenberg, MD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Medical Center | Nijmegen | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27162003 | Result | Bastiaans DE, Bartels-Wilmer CM, Colbers AP, Heijens CA, Velthoven-Graafland K, Smeets OS, Vink N, Harbers VE, Warris A, Burger DM. A new paediatric formulation of valaciclovir: development and bioequivalence assessment. Arch Dis Child. 2016 Oct;101(10):971-2. doi: 10.1136/archdischild-2015-310266. Epub 2016 May 9. No abstract available. |
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| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077483 | Valacyclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 |
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| valacyclovir oral solution | Drug | 16 healthy adult volunteers (18-55 yr) will be exposed to 10 ml once |
|
| D017193 |
| Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |